MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Great Vessel Perforation (2152); Blood Loss (2597)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least 5 injections were performed with balloon catheter 2af283 with lot number 75268 with system notice 50032 ¿the safety system detected a compromised outer vacuum triggered¿ on one injection on the date of event.This system notice is not related to the reported clinical issue.Clinical issues were encountered during the procedure.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, it was noted that the physician had a difficult time finding the right inferior pulmonary vein (ripv) and the mapping catheter may have entered into an intermediate small right pulmonary vein.Soon after, the patient started to cough and the nurse noticed blood was being expectorated.The physician stopped the catheter manipulation to check on the patient and consulted with vascular experts.Medication was administered to reverse the bleeding.The bleeding stopped quickly and the patient stopped coughing.The case was aborted.The patient was ok and a scan was performed which revealed some bleeding around the small intermediate right pulmonary vein that was stable.No further patient complications have been reported as a result of this event.Additional information reported that a perforation was suspected due to the strong push on the mapping catheter into the small vein.Furthermore, it was confirmed that when the perforation occurred, the sheath, balloon catheter, and mapping catheter were all in the heart.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8043791
• MDR Text Key: 126309164
• Report Number: 3002648230-2018-00788
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 77285
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 76